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Deutetrabenazine for Tardive Dyskinesia in Intellectual/Developmental Disabilities

This study is looking at how safe and effective a medication called deutetrabenazine is for treating tardive dyskinesia (TD) in people with intellectual and developmental disabilities (IDD). TD is a movement disorder that can cause uncontrolled movements, often linked to certain medications. You may be able to join if you are 18 to 89 years old, have a diagnosis of IDD, and have had TD for at least three months. The study will measure changes in your TD symptoms using a special scoring system over 24 weeks. Researchers also want to see how deutetrabenazine affects daily activities and compare results to people without IDD who have taken the medication. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving deutetrabenazine. It plans to enroll 25 participants.
What's involved
You would receive deutetrabenazine oral capsules for 24 weeks. Your AIMS total scores will be measured at the beginning and end of this treatment period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks from the start of treatment, based on the primary endpoint timeframe.

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NCT06997198

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Recruiting
PHASE4Ages 18–89InterventionalTreatment
University Hospitals Cleveland Medical Center
~25 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Deutetrabenazine Oral Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in AIMS total scores of items 1-7
Measured over Baseline and 24 weeks from start of treatment

Conditions

Tardive Dyskinesia
Intellectual Disability
Developmental Disabilities

Explore related trials

Developmental DisorderIntellectual DisabilityTardive dyskinesia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Stephen Ruedrich, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

Who to contact

Melissa Stasko, JD, MA
[email protected]
216-370-2090
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of IDD (IQ \< 70; social/adaptive dysfunction, onset \< age 22) as per DSM-5
Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD).
Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion
Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth control throughout study duration.
Subject able to comply with scheduled visits and assessments
Consent of subject, or legally authorized representative to study protocol.
Able to understand and answer questionnaires
Able to comply with scheduled visits
Ability to be primary Caregiver for 24 weeks of study

Exclusion

Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).
Treatment with any investigational drug in the 30 days prior to study entry.
Currently taking a strong CYP2D6 inhibitor such as fluoxetine, paroxetine, quinidine, bupropion. Current treatment with strong anticholinergic agents, monoamine oxidase inhibitors, metoclopramide, dopamine agonists, L-DOPA, or stimulants within past 30 days, or botulinum toxin within the past 3 months.
Any unstable medical condition in the 60 days prior to study entry.
Pregnant or breast-feeding
Current or recent hepatic impairment
History of neuroleptic malignant syndrome
History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure.
History of substance abuse or dependence in the 3 months prior to study entry.
Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.
Inability to take study medications
Unable to complete questionnaires
Unable to comply with scheduled visits
Will not be a primary Caregiver for the 24 weeks of the study

What this trial measures

  • Change in AIMS total scores of items 1-7Baseline and 24 weeks from start of treatment

    The Abnormal Involuntary Movement Scale (AIMS) has been used for many years as the gold standard for this purpose and the amount of improvement (change in movement intensity, and reduction in AIMS scores) have been assessed clinical significance in rating improvement. A number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine. The minimum value of the AIMS total score of items 1-7 is 0 and the maximum value is 49. Higher total AIMS scores mean worse outcomes.